Catalog Number IAB-06840-U |
Device Problem
Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/20/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that when the iab was inserted into the artery, it became bent.Then when the iab was connected to the pump, it was found to be ruptured.As a result, the iab was removed and a 2nd iab was inserted at the same insertion site.No patient harm or injury.The patient status is reported as "fine".See associated mdr #3010532612-2023-00520.
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Event Description
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It was reported that when the iab was inserted into the artery, it became bent.Then when the iab was connected to the pump, it was found to be ruptured.As a result, the iab was removed and a 2nd iab was inserted at the same insertion site.No patient harm or injury.The patient status is reported as "fine".See associated mdr #3010532612-2023-00520.
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Manufacturer Narrative
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Qn#(b)(4).The reported complaint for iab kinked was not able to be confirmed as the product was not returned for investigation.Based on a review of the device history record (dhr), the product met specification upon release.The root cause of the complaint was undetermined.No further action required at this time.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.
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Search Alerts/Recalls
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